Applied Technical Services
★★★★★
3.5
/ 5
•
11 reviews
FDA 510(k) Regulatory Consulting Services
Applied Technical Services is a consulting firm specializing in FDA 510(k) regulatory consulting. With 12 years of experience, they provide comprehensive support for medical device companies seeking 510(k) clearance across all device classes (I, II, and III). Their services include 510(k) consulting and in-house testing lab capabilities.
About
**Who they are**
Applied Technical Services is a provider of FDA 510(k) Regulatory Consulting Services.
**Expertise & scope**
* FDA 510(k) Submission Services
* Regulatory Consulting
**Reputation / proof points**
* Coverage: US
* Languages: English
Applied Technical Services is a provider of FDA 510(k) Regulatory Consulting Services.
**Expertise & scope**
* FDA 510(k) Submission Services
* Regulatory Consulting
**Reputation / proof points**
* Coverage: US
* Languages: English
Additional information
Applied Technical Services focuses on guiding clients through the FDA 510(k) submission process. Their services are designed to assist companies in navigating the regulatory requirements for bringing medical devices to the US market. Buyers engaging with Applied Technical Services can expect support tailored to the specific demands of 510(k) submissions.
Buyer Snapshot
Best for
- Companies seeking FDA 510(k) submission guidance
- Businesses requiring regulatory consulting for US market entry
How engagement typically works
- Direct consulting services
- Support for regulatory pathways
Typical deliverables
- FDA 510(k) submission strategy
- Regulatory consulting reports
Good to know
- Best when focused on US market FDA 510(k) submissions.
HQ:
Marietta, United States
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Predicate Research & Substantial Equivalence Strategy
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k)
Device Types Supported:
Other
Years Experience:
57
Num510k Submitted:
10
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Engagement Models:
Project-based
Accepting New Clients:
Yes
Supports Estar:
No
Supports Rta Remediation:
No
Supports Predicate Research:
Yes
Supports Labeling Review:
No
Provides Submission Project Management:
No
